MasticationPhase 2/3NCT05503420
Effects of Masticatory Muscles Training Exercises on the Masticatory Performance and Rehabilitation of Stroke Patients
A Phase 2/3 study testing Masticatory muscle training exerciser in people with Mastication, run by The University of Hong Kong at 1 site in China.
Trial summary
Stroke is one of the top causes of death and morbidity of adults, especially the older population in the economically developed countries. People who survives from stroke attack usually suffer from a wide range of impairments and often have poor chewing ability even when they are physically well enough to be… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Mastication
- What is being tested?
- Masticatory muscle training exerciser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 30 years or above, first-time stroke patient within 20 days post-stroke and medical status being stable
Who cannot join
- unable to follow basic instructions, unable to communicate clearly, being bed-ridden, dysphagic (on nasogastric tube) and not having any natural teeth in either of the jaws
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Edward Lo, 852-28590292, edward-lo@hku.hk
About this study
Official title: Randomized Controlled Trial on Effects of Masticatory Muscles Training Exercises on the Masticatory Performance and Rehabilitation of Stroke Patients
Stroke is one of the top causes of death and morbidity of adults, especially the older population in the economically developed countries. People who survives from stroke attack usually suffer from a wide range of impairments and often have poor chewing ability even when they are physically well enough to be discharged from hospital. Aim of this proposed study is to investigate the effects of providing masticatory muscles training exercises on the masticatory performance, nutrition intake and general health conditions of stroke rehabilitation patients. Around 100 stroke patients undergoing rehabilitation in the rehabilitation centre in Tung Wah Eastern Hospital, Hong Kong, will be recruited and allocated randomly into one of two study groups: Group 1 will be provided with an oral device for chewing muscles exercises and training exercises on chewing (the intervention group); and Group 2 will just follow the current stroke rehabilitation programme which does not have any training in chewing (a negative control group). A video on the chewing muscles exercises will be produced and placed online for the participants in Group 1 to view on demand. Data from the participants in both groups will be collected at four time points: at baseline before provision of the interventions, and at around 1, 3 and 6 months after the intervention. Each participant will be interviewed by a trained interviewer and undergo a clinical examination. The information collected will include the participant's oral health status such as numbers of decayed teeth and occluding tooth pairs, and their masticatory performance measured both objectively by chewing on a colour-changeable gum and subjectively by a chewing function questionnaire. Their type of stroke (ischemic or hemorrhagic) and general health conditions such as physical function status and nutrition intake will be recorded. The masticatory performance and general health conditions of the two groups of study participants at baseline and follow-up evaluations will be compared to assess if the masticatory muscles training exercises can improve the rehabilitation outcomes. It is anticipated that this proposed randomized trial will provide high-level clinical evidence to support the introduction of masticatory muscles training exercises into the rehabilitation programme of stroke patients and to inform how the exercises will benefit the patients, such as improving their chewing ability and general health conditions.
- Conditions
- Mastication
- Being tested
- Masticatory muscle training exerciser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masticatory muscle training exerciserDevice
In addition to the normal stroke rehabilitation training, the participants will be instructed on an active range of motion (AROM) exercise to improve coordination of the masticatory muscles. This part will be performed with a 5-second hold at the end of the range of motion for each motion, with 10 repetitions performed for each motion. In addition, each participant will be provided with a device, a U-shaped apparatus covered by silicon and having 3 small springs inside to provide resistance during chewing to be placed inside the mouth for carrying out a chewing exercise. The participant will be instructed to perform a chewing exercise using the device for around 10 minutes each time, twice a day, and 7 days per week. The exercise includes isotonic and isometric muscle training.
| Study group | Role | What they receive |
|---|---|---|
| exerciser | Experimental | Participants will be asked to use a masticatory muscle training exerciser twice daily, 10 minutes each time, and also perform active range of motion for 4 minutes each time. Receives: Device: Masticatory muscle training exerciser |
| Control | No intervention | Participants in this group will receive the normal stroke rehabilitation training in the centre without additional provision of masticatory muscles training exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
masticatory performance
colour of a color-changeable gum after chewing for 90 seconds measured in a* value
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Oct 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MasticationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503420
- Sponsor's protocol ID
- UW21-522
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Effects of Masticatory Muscles Training Exercises on the Masticatory Performance and Rehabilitation of Stroke Patients
- ClinicalTrials.gov ID
- NCT05503420
- Acronym / sponsor ID
- UW21-522
- Conditions
- Mastication
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is one of the top causes of death and morbidity of adults, especially the older population in the economically developed countries. People who survives from stroke attack usually suffer from a wide range of impairments and often have poor chewing ability even when they are physically well enough to be discharged from hospital. Aim of this proposed study is to investigate the effects of providing masticatory muscles training exercises on the masticatory performance, nutrition intake and general health conditions of stroke rehabilitation patients. Around 100 stroke patients undergoing rehabilitation in the rehabilitation centre in Tung Wah Eastern Hospital, Hong Kong, will be recruited and allocated randomly into one of two study groups: Group 1 will be provided with an oral device for chewing muscles exercises and training exercises on chewing (the intervention group); and Group 2 will just follow the current stroke rehabilitation programme which does not have any training in chewing (a negative control group). A video on the chewing muscles exercises will be produced and placed online for the participants in Group 1 to view on demand. Data from the participants in both groups will be collected at four time points: at baseline before provision of the interventions, and at around 1, 3 and 6 months after the intervention. Each participant will be interviewed by a trained interviewer and undergo a clinical examination. The information collected will include the participant's oral health status such as numbers of decayed teeth and occluding tooth pairs, and their masticatory performance measured both objectively by chewing on a colour-changeable gum and subjectively by a chewing function questionnaire. Their type of stroke (ischemic or hemorrhagic) and general health conditions such as physical function status and nutrition intake will be recorded. The masticatory performance and general health conditions of the two groups of study participants at baseline and follow-up evaluations will be compared to assess if the masticatory muscles training exercises can improve the rehabilitation outcomes. It is anticipated that this proposed randomized trial will provide high-level clinical evidence to support the introduction of masticatory muscles training exercises into the rehabilitation programme of stroke patients and to inform how the exercises will benefit the patients, such as improving their chewing ability and general health conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exerciser | Experimental | Device: Masticatory muscle training exerciserParticipants will be asked to use a masticatory muscle training exerciser twice daily, 10 minutes each time, and also perform active range of motion for 4 minutes each time. |
| Control | No intervention | –Participants in this group will receive the normal stroke rehabilitation training in the centre without additional provision of masticatory muscles training exercises. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 30 years or above, first-time stroke patient within 20 days post-stroke and medical status being stable
Key exclusion criteria (1 listed)
- unable to follow basic instructions, unable to communicate clearly, being bed-ridden, dysphagic (on nasogastric tube) and not having any natural teeth in either of the jaws
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masticatory muscle training exerciserIn addition to the normal stroke rehabilitation training, the participants will be instructed on an active range of motion (AROM) exercise to improve coordination of the masticatory muscles. This part will be performed with a 5-second hold at the end of the range of motion for each motion, with 10 repetitions performed for each motion. In addition, each participant will be provided with a device, a U-shaped apparatus covered by silicon and having 3 small springs inside to provide resistance during chewing to be placed inside the mouth for carrying out a chewing exercise. The participant will be instructed to perform a chewing exercise using the device for around 10 minutes each time, twice a day, and 7 days per week. The exercise includes isotonic and isometric muscle training. | Device | exerciser |
Primary outcome
masticatory performance
Time frame: 6 months
colour of a color-changeable gum after chewing for 90 seconds measured in a* value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Masticatory muscle training exerciser in people with Mastication, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
masticatory performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.